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Impact of abiraterone on patient-related outcomes in metastatic castration-resistant prostate cancer: current perspectives

机译:阿比特龙对转移性去势抵抗性前列腺癌患者相关结局的影响:当前观点

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摘要

Abiraterone acetate has established a major role in the treatment paradigm of metastatic castration-resistant prostate cancer ever since pivotal trials, COU-AA-301 and COU-AA-302, have shown benefit in both the second-line and first-line (post- and pre-chemotherapy) setting, respectively, with improvement in overall survival as well as secondary end points such as prostate-specific antigen (PSA) and radiographic response rates, time to PSA progression, and progression-free survival. There has been a lot of interest and emphasis in the evaluation of patient-related outcomes (PROs) as it relates to quality of life, pain, adverse events, fatigue, and among others, in the use of different agents that have been shown to improve survival. This review examines the companion PROs in conjunction with abiraterone acetate use. This is particularly relevant since PROs are increasingly viewed as a key metric for drug label claims in granting approval across regulatory agencies, including the US Food and Drug Administration and the European Medicines Agency.
机译:自从关键性试验COU-AA-301和COU-AA-302在二线和一线治疗中均显示获益以来,乙酸阿比特龙酯已在转移性去势抵抗性前列腺癌的治疗范例中发挥了重要作用。 -和化学疗法前)设置,分别提高了总生存率和次要终点,例如前列腺特异性抗原(PSA)和放射照相反应率,PSA进展时间和无进展生存期。人们对患者相关结局(PROs)的评价引起了极大的兴趣和重视,因为它与生活质量,疼痛,不良事件,疲劳等相关,并且与使用不同的药物相关。提高生存率。这篇评论结合醋酸阿比特龙的使用来检查伴随的PRO。这一点特别重要,因为在越来越多的监管机构(包括美国食品和药物管理局和欧洲药品管理局)批准后,PRO越来越被视为药品标签声明的关键指标。

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